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DEVELOPMENT AND VALIDATION OF DERIVATIVE SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF ATORVASTATIN CALCIUM AND AMLODIPINE BESYLATE IN TABLET DOSAGE FORM

International Journal of Pharmacy and Pharmaceutical Sciences (Impact Factor: 1.59). 06/2012; 3(4):195-197.

ABSTRACT Atorvastatin calcium (AT) is hypolipidemic agent and Amlodipine besylate (AM) is calcium channel blocker. The combination of both drugs is used in treatment of hypertension. The present communication deals with development of simple, sensitive, rapid and economical method for simultaneous estimation of atorvastatin calcium and amlodipine besylate in combined dosage form. The AT and AM stock solutions are prepared in (50:50 V/V) methanol: water. The method of analysis is derivative spectroscopy to eliminate spectral interference by measuring absorbances at 241nm and 250 nm for AM and AT respectively. The AT and AM are linear in concentration range of 0-14 µg/ml and 0-7 µg/ml respectively. The limit of detection (LOD) and limit of quantitation (LOQ) of AM was 0.29 and 0.75 µg respectively. The limit of detection (LOD) and limit of quantitation (LOQ) of AT was 0.21 and 0.60 µg respectively. The results of analysis were validated by ICH Q2B (R1). The results of recovery studies and precision were found to be within limits. INTRODUCTION Atorvastatin calcium (AT)[ (ßR,dS)-2-(4-fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4[(phenylamino) carbonyl]-1H-pyrrole-1-heptenoic acid calcium salt is a hypolipidemic agent, which inhibits HMG CO-A reductase, enzyme involved in lipid synthesis 1 Amlodipine besylate (AM), [3-ethyl-5-methyl (4RS)-2-[(2-aminoethoxy) methyl]-4-(2-chlorophenyl)-methyl-1-dihydropyridine-3, 5-dicarboxylate benzenesulphonate is a calcium channel blocker, used in hypertension treatment. Both are official in BP and EP

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